Status:
COMPLETED
The Impact of Steviol Glycosides on Human Gut Microflora Profile and Function
Lead Sponsor:
Cargill
Collaborating Sponsors:
INQUIS Clinical Research
Conditions:
Healthy
Human Gut Microflora
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Diet and dietary ingredients can have a profound effect on gut microflora, both positive and negative. The reported effects on low and non caloric sweeteners (LNCS) on human gut microflora are contrad...
Detailed Description
This is a double blind randomized parallel study with 2 treatments to understand the effects of a low energy steviol glycoside beverage vs. a sucrose sweetened beverage on gut microflora profile and f...
Eligibility Criteria
Inclusion
- Generally healthy
- Non-pregnant, non-lactating individuals at least 25 of whom are male and 25 female
- Aged 18-50 years, inclusive
- BMI 18.5 to 24.9, inclusive
- Has access to a phone or tablet and wifi (to complete app based 3DDR)
- Consumption of ≤600ml (20oz) high intensity sweetened beverages per week for 1 month before screening
- Normal bowel frequency (≥3 per week)
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study Principal investigator
- Willing to not significantly alter their normal diet, physical activity routine, fiber intake or consume prebiotics or probiotics during the 8-week treatment period.
- Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP
Exclusion
- Failure to meet any one of the inclusion criteria
- Use of prebiotic or probiotic supplement one month prior to the study and during the entire duration of the study
- Smokers (cigarettes, vape or marijuana)
- Habitual consumption of \>1.5L sugar sweetened beverages (eg. juice, soft drinks) per day
- High alcohol consumption (\>14 drinks per week and \>4 drinks per day for males; and \>7 drinks per week and \>3 drinks per day for females), or history of alcohol abuse. Alcohol intake during the study must stay below these limits listed above
- History of major trauma or major medical or surgical event requiring hospitalization within 3 months of screening
- Individuals with diabetes, bariatric surgery, celiac disease, phenylketonuria, inflammatory bowel disease, moderate or severe renal failure, moderate or severe liver disease or any other medical conditions or medications that increase risk to the subject or others or may affect the results, as judged by the Principal Investigator
- Use of antibiotics within 3 months of screening or with a condition likely to require the use of antibiotics during the study
- Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines
- Known intolerance, sensitivity, or allergy to any ingredients in the study test beverages.
- Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification.
- Reported weight change of \> 5kg in the preceding 3 months
- Employed by the study sponsor or affiliated organizations
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2022
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT05264636
Start Date
February 15 2022
End Date
August 29 2022
Last Update
April 28 2023
Active Locations (1)
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1
Inquis
Toronto, Ontario, Canada, M5C 2N8